Dycal® Radiopaque Calcium Hydroxide Composition 61106501

GUDID D002611065011

Dycal® in Tubes, Standard Pack - Shade Dentin

DENTSPLY INTERNATIONAL INC.

Calcium hydroxide dental cement

• Primary Device ID: D002611065011
• NIH Device Record Key: 99d64778-d774-417d-b935-655ca0414054
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dycal® Radiopaque Calcium Hydroxide Composition
• Version Model Number: 61106501
• Catalog Number: 61106501
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.como

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D002611065011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K780384

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-14
• Device Publish Date: 2022-04-06

On-Brand Devices [Dycal® Radiopaque Calcium Hydroxide Composition]

• D002623401Y1: Dycal® Radiopaque Calcium Hydroxide Composition - Export Package - Ivory
• D002611066061: Dycal® in Tubes, ECO (6-Packs) - Shade Dentin
• D002611065011: Dycal® in Tubes, Standard Pack - Shade Dentin
• D002611056061: Dycal® in Tubes, ECO (6-Packs) - Shade Ivory
• D002611055011: Dycal® in Tubes, Standard Pack - Shade Ivory
• D0026231170: Dycal® Placement Instrument Refill
• D0026234501: Dycal® Radiopaque Calcium Hydroxide Composition Complete Package - Dentin Shade
• D0026234001: Dycal® Radiopaque Calcium Hydroxide Composition Complete Package - Ivory Shade